Device Classification Name |
block, beam-shaping, radiation therapy
|
510(k) Number |
K111676 |
Device Name |
APEX |
Applicant |
Elekta Limited |
LINAC HOUSE, FLEMING WAY |
CRAWLEY,
GB
RH10 9RR
|
|
Applicant Contact |
Patrick Hull |
Correspondent |
Elekta Limited |
LINAC HOUSE, FLEMING WAY |
CRAWLEY,
GB
RH10 9RR
|
|
Correspondent Contact |
Patrick Hull |
Regulation Number | 892.5710
|
Classification Product Code |
|
Date Received | 06/15/2011 |
Decision Date | 09/30/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|